BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2974316 · Received January 25, 2013

    Report

    Report Number
    3004464228-2013-00069
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 29, 2012
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE WAS EVALUATED, AND THE PRODUCT PERFORMED AS DESIGNED DURING TESTING. NO DEFECT THAT WOULD HAVE CAUSED THE CANNULA NOT TO INSERT PROPERLY WAS FOUND. THE CUSTOMER REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. IT CANNOT BE CONFIRMED, NOR EXCLUDED THROUGH LABORATORY INVESTIGATION. THE OMNIPOD USER GUIDE WARNS "CHECK OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE OR DISLODGED CANNULA MAY INTERRUPT INSULIN DELIVERY," "BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED. IF IT IS UNTREATED, SEVERE HYPERGLYCEMIA CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA). DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, OR DEATH. IF INSULIN DELIVERY IS INTERRUPTED FOR ANY REASON, YOU MAY NEED TO REPLACE THE MISSING INSULIN- USUALLY WITH AN INJECTION OF RAPID-ACTING INSULIN. ASK YOUR HEALTHCARE PROVIDER FOR INSTRUCTIONS ON HANDLING INTERRUPTED INSULIN DELIVERY," AND "IF YOU OBSERVE BLOOD IN THE CANNULA, CHECK YOUR BLOOD GLUCOSE MORE FREQUENTLY TO ENSURE INSULIN DELIVERY HAS NOT BEEN AFFECTED. IF YOU EXPERIENCE UNEXPECTED ELEVATED BLOOD GLUCOSE LEVELS, CHANGE YOUR POD." LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS REMOVED THE POD WHEN HIS BLOOD GLUCOSE MEASURED 386 MG/DL. HE NOTICED THE POD WAS LEAKING AND THE ADHESIVE WAS WET. THERE WAS BLOOD IN THE CANNULA, AND IT WAS NOT PROPERLY INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36516 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30944

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR